FDA/OHRP IRB Registration

On January 15, 2009, the Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) issued final rules mandating new or expanded registration of Institutional Review Boards (IRBs). The Office for Human Research Protections (OHRP) IRB registration system will be compatible with the requirements of both OHRP and FDA regulations.

IntegReview IRB is in compliance with current IRB registration requirements as it is registered with the Office of Human Research Protections (OHRP). Registration numbers assigned by OHRP/FDA under the IRB Organization (IORG) number IORG0000689 are:

Federalwide Assurance (FWA)

What is a Federalwide Assurance (FWA)?

The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP for institutions engaged in non-exempt human subjects research conducted or supported by HHS. Under an FWA, an institution commits to HHS that it will comply with the requirements set forth in 45 CFR part 46, as well as the Terms of Assurance.

FWAs also are approved by OHRP for federalwide use, which means that other federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely on the FWA for the research that they conduct or support. Institutions engaging in research conducted or supported by non-HHS federal departments or agencies should consult with the sponsoring department or agency for guidance regarding whether the FWA is appropriate for the research in question.

There is a single version of the FWA and the Terms of Assurance for domestic (U.S.) institutions and international (non-U.S.) institutions.

When is the FWA required to be submitted to the IRB?

The IRB requires the FWA number from a registered institution when the institution is engaged in human subjects research that is not exempt from the regulations, and is federally-supported by the U.S. Government providing any funding or other support.